Animal Medicinal Drug Use Clarification Act (AMDUCA)

To use this electronic reference guide, follow the questions using the interactive Extralabel Drug Use (ELDU) Algorithm.
 

Requirements for Use

ELDU is permitted only by or under the supervision of a veterinarian.
ELDU is allowed only for FDA approved animal and human drugs.
The 'valid veterinarian-client-patient-relationship' is a prerequisite for all ELDU.

21 CFR Part 530.3 defines the federally "valid VCPR" - A valid veterinarian-client-patient relationship is one in which:

(1) A veterinarian has assumed the responsibility for making medical judgments regarding the health of (an) animal(s) and the need for medical treatment, and the client (the owner of the animal or animals or other caretaker) has agreed to follow the instructions of the veterinarian;

(2) There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s); and

(3) The practicing veterinarian is readily available for follow-up in case of adverse reactions or failure of the regimen of therapy. Such a relationship can exist only when the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.”

ELDU for therapeutic purposes only (animal's health is suffering or threatened). Not drugs for production use.
Rules apply to dosage form drugs and drugs administered in water. ELDU in feed is prohibited.
ELDU is not permitted if it results in a violative food residue, or any residue which may present a risk to public health.
FDA prohibition of a specific ELDU precludes such use.

 

Drugs Prohibited for Extralabel Use in Food Animals

(Current as of April 2012. Check for updates on the FDA Web site at www.fda.gov/cvm)

  • Chloramphenicol
  • Clenbuterol
  • Diethylstilbestrol (DES)
  • Dimetridazole
  • Ipronidazole
  • Other Nitroimidazoles
  • Furazolidone, Nitrofurazone, Other Nitrofurans
  • Sulfonamide drugs in lactating dairy cows (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine)
  • Fluoroquinolones
  • Glycopeptides (example: vancomycin)
  • Phenybutazone in female dairy cattle 20 months of age or older
  • Adamantane and neuraminidase inhibitor classes of drugs that are approved for treating or preventing influenza A are prohibited therapy in chickens, turkeys, and ducks (Effective: June 20, 2006)
  • Cephalosporin (excluding cephapirin) in cattle, swine, chickens, or turkeys
    • Using cephalosporin drugs at unapproved dose levels, frequencies, durations or routes of administration is prohibited;
    • Using cephalosporin drugs in cattle, swine, chickens or turkeys that are not approved for use in that species (e.g., cephalosporin drugs intended for humans or companion animals);
    • Using cephalosporin drugs for disease prevention.
 

Record Requirements

  • Identify the animals, either as individuals or a group.
  • Animal species treated.
  • Numbers of animals treated.
  • Conditions being treated.
  • The established name of the drug and active ingredient.
  • Dosage prescribed or used.
  • Duration of treatment.
  • Specified withdrawal, withholding, or discard time(s), if applicable, for meat, milk, eggs, or animal-derived food.
  • Keep records for 2 years.
  • FDA may have access to these records to estimate risk to public health.
 

Label Requirements

  • Name and address of the prescribing veterinarian.
  • Established name of the drug.
  • Any specified directions for use including the class/species or identification of the animal or herd, flock, pen, lot, or other group; the dosage frequency, and route of administration; and the duration of therapy.
  • Any cautionary statements.
  • Your specified withdrawal, withholding, or discard time for meat, milk, eggs, or any other food.